The purpose of this study is to evaluate the safety of deploying and implanting the Altura Abdominal Aortic Aneurysm (AAA) Endograft in the treatment of abdominal aortic aneurysms in subjects who are candidates for open surgical aneurysm repair.

Evaluate the feasibility of using Altura AAA Endograft. Feasibility is comprised of acute clinical and technical success measured at the time of procedure. Long-term safety will be evaluated at 6 months, 1 year and 2 years.

Subject has thrombus, calcification and/or plaque that may compromise sealing

Subject has had a myocardial infarction within six (6) months prior to enrollment.

Subject has current angina or other active cardiac condition such as congestive heart failure, untreated or worsening atrial arrhythmia, ventricular arrhythmia, or valvular disease.

Subject has undergone other major surgery within the 30 days prior to enrollment.

Subject is pregnant or nursing.

Known allergy to nitinol or polyester or contrast material that cannot be pretreated.

Subject is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta.

Subject has connective tissue disease (e.g., Marfan's syndrome).

Subject has a bleeding disorder or anemia defined as hemoglobin < 9.0 mg/dL.

Subject is hypercoagulable.

Subject is on dialysis or has compromised renal function as reflected by a serum creatinine >2.2 mg/dL.

Subject has compromised hepatic function as measured by SGPT (ALT) > three (3) times the upper limit of normal.

Subject has active systemic infection.

Subject is participating in another research study involving an investigational agent for the treatment of AAA.

Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment and the procedures and evaluations pre- and post-treatment.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01346943